Process Engineer II

3 weeks ago


Brockton, Massachusetts, United States BioSpace, Inc. Full time
Job Details

At BioSpace, Inc., we are seeking a highly skilled Process Engineer II to join our team. This role will be responsible for process development, process characterization, scale-up, and technology transfer activities, supporting new and existing pharmaceutical products.

Responsibilities
  • Contribute to the design and execution of process development and process engineering experiments for fermentation/chromatography or other project-related processes.
  • Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.
  • Key contributor to process development strategies to define manufacturing processes for clinical and commercial products.
  • Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.
  • Utilize appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development.
  • Manage external vendors and contractors as related to drug product manufacturing services and products.
  • Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
  • Prepare technical reports, publications, and oral presentations.
Requirements
  • Bachelor's degree with 3+ years of pharmaceutical experience strongly preferred.
  • Strong background in fermentation/chromatography purification of biopharmaceutical proteins both small scale and large scale.
  • Strong background operating fermentation/chromatography equipment in the preparation of proteins at small and large scale.
  • Strong background in pharmaceutical development as it relates to process development/optimization.
  • Demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines.
  • Demonstrated record of implementing novel and creative solutions to overcome process development obstacles.
  • Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.
  • Working knowledge of GLPs and cGMPs during pharmaceutical development and commercial manufacturing.
  • Strong interpersonal skills and the ability to work in a fast-paced, multidisciplinary environment.
  • Strong verbal and written communication skills are essential.
  • Experience managing third-party vendors is a plus.
  • High energy, innovative 'can-do' attitude is required.


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